Kornimate/medical-research-clean huggingface dataset:
pain responses in patients on long-term opioid therapy for chronic pain

Conditions: Chronic Pain

Summary: the mgh center for translational pain research is seeking patients with chronic pain for a research study. the study is looking at the effect of opioid (narcotic) pain medicines on pain sensation, threshold and tolerance.

the study consists of one visit, in which an interview, physical exam, lab work (urine test) and sensory testing will be done. the testing (quantitative sensory testing) is noninvasive (no needles) and involves heat and cold stimulation. compensation and some parking reimbursement provided.

Eligibility criteria:
a. inclusion/exclusion criteria inclusion criteria for the group with chronic pain on chronic treatment with opioids: 1. subject has chronic pain and is on stable chronic opioid treatment (morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for chronic pain for at least one month. we consider stable treatment if no change in the type and amount of daily opioid treatment for one month. only patients with minimal daily opioid dose of at least 30 mg morphine equianalgesic dose will be included. 2. subject is age 18 to 65 years. inclusion criteria for the group with chronic pain on chronic treatment with non-opioids (currently not recruiting): 1. subject has pain and is on stable chronic non-opioid treatment for chronic pain for at least one month. 2. subject is age 18 to 65 years. inclusion criteria for the group of opioid-naive healthy volunteers without chronic pain (currently not recruiting): 1. subject is opioid naive meaning he/she did not receive chronic opioid treatment in the past or present, and did not receive acute treatment with opioids in the last 1 month 2. subject does not have pain 3. subject is age 18 to 65 years. exclusion criteria for all groups: 1. subject has lost tactile sensation in the sites for qst testing (upper extremities) 2. subject has scar tissue or acute injury in the skin areas for qst testing (upper extremities) 3. subject has neurological disease or a medical condition causing peripheral polyneuropathy and sensory changes (including but not limited to diabetes, alcoholism, aids, thyroid disease, liver or kidney disorders). it is the presence of neuropathy, not the causative disease itself, that is the exclusion criteria. 4. subject had recent therapy that may influence qst results, e.g., neuroablative procedure involving upper extremities within six-months; peripheral neurolytic block within two-months; injection therapy for pain within four-weeks; sympathetic block within six months. 5. subject has litigation pending relative to their chronic pain. 6. subject has major psychiatric disorder (major depression disorder; bipolar disorder; schizophrenia; anxiety disorder; psychotic disorders; eating disorders; alcohol or drug dependence; attention deficit hyperactivity disorder); any known history of these conditions will exclude participation. 7. subject has used illicit drugs within past 6 months. 8. subject is pregnant

Keywords: pain
core stability exercises and general exercises in patients with low back pain

Conditions: Low Back Pain

Summary: effectiveness of core stability exercises and general exercises in patients with low back pain

the study focuses on understanding core stability exercises and general exercises in patients with low back pain low back pain (lbp) is an common state with a lifetime occurrence reported to be as high as about 80% . about 5-10% of patients have chronic pain (clbp), responsible for high direct and indirect (lost production and lost household productivity) costs highly person suffering from disability

Eligibility criteria:
inclusion criteria: 1. adults (30-45 years) 2. chronic low back pain (\>3 months) 3. pain intensity ≥ 4/10 on numeric pain rating scale (nprs) 4. ability to perform exercises 5. willingness to participate and provide informed consent 6. no planned spinal surgery or injection within study duration exclusion criteria: 1. severe spinal pathology (fracture, tumor, infection) 2. neurological deficits (numbness, weakness, paralysis) 3. recent spinal surgery or injection (\<6 months) 4. pregnancy or breastfeeding 5. . severe mental health conditions (e.g., depression, anxiety) musculoskeletal conditions: 1. severe osteoporosis 2. spinal stenosis 3. scoliosis 4. recent musculoskeletal injury (\<6 months) 5. fibromyalgia or widespread pain syndr

Keywords: low back pain
a safety & effectiveness study of intravenous anidulafungin with ambisome® for treatment of invasive aspergillosis (ia).

Conditions: Aspergillosis

Summary: the combination of anidulafungin plus ambisome® may offer an improved outcome for patients treated for invasive aspergillosis (ia). the purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus ambisome® in treated patients located in the united states, europe, and south africa.


Eligibility criteria:
inclusion criteria: * diagnosis of definite ia outside the pulmonary system or definite or probable pulmonary ia * life expectancy: greater than 72 hours exclusion criteria: * pregnant female * hypersensitivity to anidulafungin or echinocandin therapy * hypersensitivity to tween 80 (polysorbate 80) or tartaric acid * hypersensitivity to amphotericin b deoxycholate or any other constituents of ambisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk. * aspergilloma-in the absence of invasive disease * abnormal blood chemistries: bilirubin \> 3 times the upper limit of normal; ast (aspartate aminotransferase) or alt (alanine aminotransferase)\> 5 times the upper limit of normal * greater than five days of therapeutic doses of systemic therapy for the current aspergillus-associated condition or a cumulative dose of more than 5 mg/kg of amphotericin, more than 25 mg/kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. prophylactic use of azoles or amphotericin is acceptable. * less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for aids-related opportunistic infections.

Keywords: invasive aspergillosis
percutaneous irreversible electroportion in unresectable liver cancer close to diaphragmatic dome

Conditions: Liver Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroportion in unresectable liver cancer close to diaphragmatic dome.

single-arm pilot clinical trial. patients will be subjected to irreversible electroporation (ire) as the sole treatment of liver cancer close to diaphragmatic dome. this pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic ire in the treatment of neoplastic nodules in the liver, with particular reference to close to diaphragmatic dome, where the current therapeutic arsenal is inadequate or counter-indicated. to perform the ire procedure the ire nanoknife™ system (angiodynamics) will be used.

Eligibility criteria:
inclusion criteria: * liver cancer diagnosed by positive biopsy or non-invasive criteria, * tumors from diaphragm is \<1 cm * not suitable for surgical resection or transplantation, * have at least one, but less than or equal to 3 tumors, * of the tumour(s) identified, each tumor must be ≤ 5 cm in diameter, * child-pugh class a,b * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x109/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * are able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * liver cancer developed on an already transplanted liver, * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.
safety and efficacy of atg003 in patients with wet age-related macular degeneration (amd)

Conditions: Macular Degeneration

Summary: this is a phase ii randomized, double-masked study comparing the safety and efficacy of atg003 (mecamylamine hcl) 1.0% and 0.3% ophthalmic solutions to placebo in patients with neovascular ("wet") age-related macular degeneration (nv-amd).


Eligibility criteria:

Keywords: amd wet amd
phase 4 study evaluating the safety of the nasal guide with tyrvaya

Conditions: Dry Eye; Keratoconjunctivitis Sicca

Summary: the objective of this study is to determine the safety of the nasal guide when utilized to aid in the administration of tyrvaya (varenicline solution 0.03mg) nasal spray

protocol opp-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of tyrvaya (varenicline solution 0.03mg) nasal spray. approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of tyrvaya for 7 days.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age 2. have provided verbal and written informed consent 3. willing to comply with all study related visits and procedures exclusion criteria: * none
innate t cells and tki discontinuation

Conditions: Chronic Myeloid Leukemia

Summary: after more than a decade of treating chronic myeloid leukemia (cml) with tyrosine kinase inhibitors (tki), the discontinuation of treatment represents the expected new revolution. the investigators has recently discovered a new innate cd8+ t population in healthy subjects, the eomes+ kir+ cd8+ t population, with anti-tumor properties. remarkably, these cells are numerically and functionally deficient in patients at diagnosis and then restored in patients in major molecular remission (mmr) on tki. our work performed in a retrospective pilot study interestingly shows a very significant increase in the proportion of cd8+ eomes+ kir+ t cells within total t cells in patients with prolonged success in stopping their itk (≥ 2 years).thus, the investigators postulate that cd8+ eomes+ kir+ t cells are a predictive signature of tki arrest success in cml. the investigators will rely on a prospective translational study of this cell contingent during treatment cessation.

to perform this research, the investigators have started a prospective translational study to collect samples in cml patients with successful versus patients who have failed tki therapy discontinuation. the investigators plan to study functional and phenotypic characteristics of innate t cells. the investigators also plan to evaluate in vitro whether immune check points inhibitors could help to restore the innate t lymphocytes population.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * diagnosis of cml-pc according to the criteria of the european leukemia net (baccarani et al, 2013) * patients treated with tki for at least 3 years (imatinib, nilotinib, dasatinib, bosutinib, ponatinib) * patients meeting the criteria of the french stim study: deep molecular response of mr4.5 type (threshold of 0.0032%) or mr5 type (threshold of 0.001%) for at least 2 years, * free subject, without guardianship or curatorship or subordination * patients benefiting from a social security system or benefiting from it through a third party exclusion criteria: * refusal to participate in the research * patients not benefiting from a social security scheme or not benefiting from it through a third party * persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies * patient having stopped treatment for another reason than: deep molecular response of mr4.5 (threshold of 0.0032%) or mr5 (threshold of 0.001%) for at least 2 years translated with www.deepl.com/translator (free version)
td-6450 sad and mad in healthy subjects

Conditions: Hepatitis C

Summary: this study consists of two parts, parts a and b. part a is a single ascending dose (sad) study in healthy subjects. part b is a multiple ascending dose (mad) study in healthy subjects.


Eligibility criteria:
inclusion criteria: * subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (fsh) level \>40 iu/l * subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg. exclusion criteria: * subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. * subject has an estimated creatinine clearance of \<90 ml/min at screening or day -1, calculated using the cockcroft-gault equation. * subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to screening, or is currently participating in another trial of an investigational drug (or medical device).

Keywords: hepatitis c
telepharmacy robotic medicine delivery unit "trmdu" assessment

Conditions: Traumatic Brain Injury; Posttraumatic Stress Disorders; Trauma; Combat Disorders; Pain

Summary: the objective of this study is to evaluate whether use of trmdu in addition to medication review leads to improved outcomes and reduced health care costs for patients when compared with medication review alone. the study will be conducted in patients assigned to department of defense (dod) warrior transition units (wtu's), similar dod units, and va polytrauma centers.

the military has been witnessing an increased number of patients with combat related impairments such as traumatic brain injury, post traumatic stress disorder and polytrauma which has lead to sub optimal medication self management. trmdu is a medical device developed by inrange systems inc. that delivers medications and emits a sound alert to assist the patient. it can be used in a hospital, clinic, or residential setting. it can be remotely accessed by the health care professionals, and it allows physicians and other prescribers to remotely change scheduling or adjust prescriptions. use of trmdu in hospital settings is expected to improve outcomes by improving medication self management, increasing adherence, reducing medication errors, and thereby associated costs. further, it may contribute to overall improvement in a patient's psychological well-being and quality of life.

Eligibility criteria:
inclusion criteria: subjects must be * at least 18 years of age * alert and oriented to person , place and time * primarily use english language for written and oral communication * have diagnosis of traumatic brain injury(tbi) multiple traumatic brain injury (mtbi), post traumatic stress disorder (ptsd) or polytrauma. * taking at least 4 chronic prescription medications * living in a participating wtu or enrolled in tampa veterans administration polytrauma outpatient treatment facility at the time of enrollment * achieve a minimum score of 24 on mini-mental state examination exclusion criteria: if patients meet following criteria they are excluded from the study * disabilities preventing safe use of the trmdu * projected life expectancy of less than 3 months

Keywords: telepharmacy robotic medicine delivery unit brain injuries stress disorders combat disorders polytrauma adherence
comparison between gamma 3 nail and ace trochanteric nail

Conditions: Pertrochanteric and Subtrochanteric Femur Fractures

Summary: pertrochanteric and subtrochanteric femur fractures will be treated with a gamma 3 nail or an ace trochanteric nail. following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.


Eligibility criteria:
inclusion criteria: * pertrochanteric or subtrochanteric femur fracture
the effect of pomegranate (punica granatum l.) peel compress application on pain and physical function status

Conditions: Pomegranate (P. Granatum) Peel Compress

Summary: osteoarthritis is the most common type of arthritis among rheumatologic diseases. complementary therapies are one of the effective methods for pain control. this study was planned as a randomized controlled experimental study. for this purpose, patients diagnosed with knee osteoarthritis who applied to the orthopedics outpatient clinic will be included. it was calculated that the study would include at least 67 patients. the study will be collected using patient information form, descriptive characteristics form, visual analog scale (vas) and womac osteoarthritis application scale. it was planned as a randomized controlled experimental study to evaluate the effect of pomegranate peel (p. granatum) compress application on pain and function status. the study was divided into 3 groups as pomegranate (punica granatum) peel compress, hot compress and control group. pomegranate (punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.

this randomized controlled experimental study was conducted to evaluate the effect of pomegranate (punica granatum) peel compress application on pain, stiffness and physical function in individuals with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * visual analog scale score of 3 and above, * those aged 45 and over, * diagnosed with knee oa by a physician according to the criteria of the american - rheumatology association (ard), * pain lasting at least 1 month or longer, * not included in any physical therapy program during the research period, a * capable of answering research questions, * agreeing to participate in the research by giving verbal and written consent exclusion criteria: * with a defined psychiatric illness, * having vision and hearing problems, * diagnosed with complex disease such as malignant, * having a wound in the application area, * with a diagnosed vascular disease, * the patient's other inflammatory disease such as rheumatoid arthritis, gout, fibromyalgia * who have had serious trauma or surgery in the last 6 months, * who have received dmards or intra-articular steroid injection therapy in the last 3 months

Keywords: pain osteoarthritis rheumatologic diseases physical function stiffness nursing
goal-directed fluid therapy in elderly patients undergoing lumbar surgery

Conditions: Lactate Blood Increase; Fluid Overload; Postoperative Complications

Summary: this is a randomized controlled clinical trial which investigates whether goal directed fluid therapy( gdt ) would show the evidence of benefit from gdt in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.

this is a single-center, randomized controlled clinical trial. patients aged \> 60 undergoing lumbar decompression surgery will be randomly assigned to either a gdt ( goal directed fluid therapy) group or a control group, who received conventional anesthesiologist-directed fluid therapy. perioperative lactic acid concentrations with 7 different time point, intraoperative fluid balance and postoperative complications from admittance to 30 days after surgery were recorded. this rct is conducted to show the evidence of benefit from gdt in terms of lactate kinetics then may reduce postoperative complications in patients undergoing spine surgery, especially in prone positions.

Eligibility criteria:
inclusion criteria: * age \> 60 years, american society of anesthesiologists score ii-iii, and expected duration of operation \> 2 h exclusion criteria: * patients with severe cardiac arrhythmia (which would affect the accuracy of stroke volume variation as an indicator of fluid responsiveness), vascular disease (which would prohibit radial artery cannulation), and mental disorder were excluded

Keywords: goal-directed fluid therapy lactate acid level postoperative complications elderly patient prone position intraoperative hemodynamics
pre-genotype nudt 15 r139c on reducing thiopurine-induced leucopenia in inflammatory bowel disease

Conditions: Thiopurine-induced Leukopenia

Summary: nudt15 r139c was comfirmed to be associated with thiopurine-induced leukopenia inflammatory bowel disease (ibd) cohort.the present study aim to explor the following questions:can optimizing thiopurine dose by nudt15 genotype reduce thiopurine-induced leucopenia?what is the influence of this optimizing strategy on clinical outcome?thus,we conduct a randomised controlled study.subject in the conventional group detect nudt15 genotype before thiopurine use and optimise dosage according to the genotype.while the subjects in the control group follow the conventional monitor strategy.the primary endpoint was the rate of leukopenia.the secondary endopoint was the efficacy of thiopurine.the follow up duration was 1 year.

we included patients diagnosis of ibd (\>18 yrs old) with indication of the use of thiopurine.group a (intervention): aza dose optimization by testing for nudt15 r139c- testing results will be informed.group b (control):aza dose optimization according to standard guideline - testing results will not be informed.the participants will be followed for 9 month. the incidence of adverse events and efficacy will be analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of ibd with indication of the use of thiopurine exclusion criteria: * contraindication of thiopurine * previous use of thiopurine * co-treatment with 5-asa or allopurinol
management of severely atrophied maxillary ridge using quad zygomatic implants

Conditions: Prosthesis Durability

Summary: this clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants

the aim of this study will be to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants and that of the atrophied maxilla rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.

Eligibility criteria:
inclusion criteria: * all patients will have healthy healed residual alveolar ridges, angle's class i maxillomandibular relations, available maxillary restorative space. this will be verified by tentative jaw relation records. exclusion criteria: * all detrimental bad habits like smoking, tmj clicking or tmj dysfunction will be excluded.